510(k) Report

FDA applicant

Hyperfine Research, Inc.

Guildford, CT3 decisions2020–20210 recalls

FDA records 3 decisions for Hyperfine Research, Inc. (Guildford, CT) from 2020 to 2021: 3 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 121 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Hyperfine Research, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 22021: 1
2020high 2 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Hyperfine Research, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hyperfine Research, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 136 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 121 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192002Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 20203cite it
  • K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc. · 20202cite it
  • K202414BrainInsightHyperfine Research, Inc. · 20211cites it

What has FDA decided for it lately?

  • K202414BrainInsightHyperfine Research, Inc. · 2021
  • K201722Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine Research, Inc. · 2020
  • K192002Lucy Point-of-Care Magnetic Resonance Imaging DeviceHyperfine Research, Inc. · 2020

All 3 as Hyperfine Research, Inc. →

Other applicant names beginning “Hyperfine”

FDA records each applicant name separately; these may or may not be the same firm.

Hyperfine, Inc. 14